A Safety and Efficacy Study for Tapentadol (CG5503) Extended Release for Patients With Painful Diabetic Peripheral Neuropathy

PHASE3CompletedINTERVENTIONAL
Enrollment

395

Participants

Timeline

Start Date

April 30, 2007

Primary Completion Date

August 31, 2008

Study Completion Date

August 31, 2008

Conditions
Diabetic Neuropathy
Interventions
DRUG

CG5503

100, 150, 200, 250 mg twice daily given for up to 15 weeks

DRUG

placebo

matching placebo twice daily for 12 weeks

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Grünenthal GmbH

INDUSTRY

lead

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY